Kornimate/medical-research-clean huggingface dataset:
scope cli (shifting care and outcomes for patients with endangered limbs - critical limb ischemia)

Conditions: Critical Limb Ischemia

Summary: given the importance of understanding cli patients' outcomes and existing gaps in knowledge, there is a pressing need to collect observational data on treatment patterns, adherence to performance measures, and outcomes that are relevant to patients and clinicians. to address this need, the current study will pilot test the research infrastructure and data elements needed to build a larger, national study collecting of the cli population. it will also provide much-needed preliminary information to identify areas of action that can be targeted in quality improvement programs for this population. most importantly, it will provide data on health status outcomes in patients with cli, as a function of individual patient characteristics (demographics, socio-economic and clinical background) and the treatments that patients have undergone. the portrait-cli study will also be well equipped to identify potential disparities in the provision of care and patients' outcomes as a function of patient's characteristics.


Eligibility criteria:
inclusion criteria: all race/ethnicity categories, english or spanish speaking, men and women * age ≥18 years * patients presenting with rutherford classification 4 (ischemic rest pain), or rutherford classification 5 (minor tissue loss: non-healing ulcer, focal gangrene with diffuse pedal ischemia), or rutherford classification 6 (major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable) at specialty clinics will prospectively be screened, regardless of whether the patient undergoes endovascular, bypass, amputation, and/or medical therapy. * diagnosis is supported by any of the following hemodynamic parameters (assessed pre- procedurally): ankle pressure lower than 70 mmhg; toe pressure lower than 50 mmhg or evidence of ischemia by transcutaneous oxygen measurement (tcpo2) \<40 or a skin perfusion pressure (spp) \<40 or angiographic evidence of significant vascular disease exclusion criteria: * no other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the enrollment * acute limb ischemia * unable to provide written informed consent * currently a prisoner
study of gemcitabine with therasphere® (yttrium-90)in patients with hepatic tumors of pancreatobiliary origin

Conditions: Pancreatic Neoplasms; Cholangiocarcinoma

Summary: therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. this form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer. the investigators want to test the safety of using gemcitabine (a chemotherapy drug) with therasphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.

patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered for the trial. the patients wre being treated in groups of thre patients. each three patients receive a pre-specified dose of gemcitabine with full dose radioembolization using theraspheres. if no significant side effects are observed then three additional three patients will be treated with a higher dose of gemcitabine. the purpose to identify the highest dose of gemcitabine that can be safely combined with theraspheres.

Eligibility criteria:
inclusion criteria: 1. histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma 2. liver predominant disease defined as - cholangiocarcinoma: liver disease should be unresectable - limited extra hepatic metastasis defined as: i. lung metastasis: 6 or less nodules with no nodule greater than 1.5 cm. ii. abdominal lymph nodes iii. pancreatic primary as long as the size is less than 4 cm in size iv. bone metastasis 3. no prior systemic therapy for advanced stage disease 4. measurable target tumors using standard imaging techniques 5. lung shunting less than 20% 6. ecog performance status 0-1 (see appendix ) 7. age ≥ 18 years 8. no other investigational agents while on protocol 9. signed informed consent exclusion criteria: 1. inadequate hepatic function: ast/alt \> five times upper limit of normal, bilirubin \>2.0 mg/dl or history of hepatic encephalopathy 2. inadequate renal function creatinine \> 2.0 mg/dl 3. inadequate bone marrow function: platelets \< 100,000/ml or absolute neutrophil count \<1500/ml 4. contraindication to angiography 5. prior external beam radiotherapy to the upper abdomen 6. clinical evidence of peritoneal metastasis or ascites 7. patients with extensive tumor replacement in the liver defined as \>50% of liver involved with tumor 8. any serious ongoing extra-hepatic disease such as infections.

Keywords: pancreatic neoplasms cholangiocarcinoma
rehabilitation of adolescents living with chronic fatigue

Conditions: Fatigue Syndrome, Chronic

Summary: previous studies have shown that health-related quality of life (hrqol) in adolescents living with chronic fatigue syndrome (cfs/me) is low if compared with healthy adolescents and adolescents living with other chronic diseases. effective strategies to improve hrqol in this group are still lacking. recently we have observed hrqol in a group of norwegian adolescents with cfs/me (not yet published), which is the background for a new study where we have planned an intervention with health promoting dialogues between patient and nurse, as a strategy to improve hrqol. in this study we have also opened to include adolescents with other chronic fatigue diagnosis with similar challenges in follow-up as in cfs/me.


Eligibility criteria:
inclusion criteria: * chronic fatigue as main symptom (including but not limited to diagnostic codes icd-10 g93.3 cfs/me, f48.0 neurasthenia, r53 fatigue) * having undergone an interdisciplinary diagnostic evaluation at the children's clinic or at the fatigue and cfs/me outpatient clinic, st. olavs hospital during the period 1.8.2019 - 1.4.2020. * being a pupil or wishing to be a pupil. exclusion criteria: * not norwegian speaking * for any reason unable to read and answer a questionnaire * for any reason unable to take part in the health promoting dialogues

Keywords: adolescent fatigue rehabilitation health promotion health-related quality of life sense of coherence emotions mood leisure activities
early changes in pain, disease activity, and ultrasound evidence of inflammatory synovitis in patients receiving jak-inhibitor vs. tnf-inhibitor therapy for active rheumatoid arthritis: a feasibility study.

Conditions: Rheumatoid Arthritis

Summary: the purpose of this phase 4 pilot study is to assess 1-year recruitment, and 6-month retention rates for participants with rheumatoid arthritis (ra) recruited to this study. secondarily, we aim to study the difference in multifaceted pain scoring and musculoskeletal ultrasound (msk-us)-detected synovitis between those treated with upadacitinib vs adalimumab.

this is a 26-week phase 4 randomized, single-blind, parallel-group, active treatment-controlled pilot/feasibility study designed to primary assess recruitment and retention rates and to secondarily assess the efficacy of upadacitinib vs adalimumab in controlling multiple measures of pain and msk-us-detected synovitis in those with active rheumatoid arthritis. participants with active ra despite combination conventional synthetic disease modifying antirheumatic drugs (csdmard), alternative biologic dmard (bdmard), or alternative targeted synthetic dmard (tsdmard) will be randomized in a 1:1 ratio to: * upadacitinib(rinvoq) 15 mg orally (po) daily or * comparison group: adalimumab(idacio) 40 mg subcutaneously (sc) every other week baseline methotrexate may be continued if patient is receiving at time of study enrollment. at 1 year after study initiation, recruitment rate over the first year will be measured and rate of 6-month participant retention will also be measured. at baseline, 1 month, 3 months, and 6 months after initiation of study drug, disease activity, pain, msk-us synovitis, and other patient important outcomes will be collected. the study will be completed after 6-months of follow-up.

Eligibility criteria:
inclusion criteria: * diagnosis of ra based on acr/eular 2020 classification criteria * moderate-to-high disease activity according to clinical disease activity indices * referred to the biologics clinic (the ottawa hospital arthritis centre) by their primary rheumatologist who practices within the division following decision to escalate to, or switch between, advanced therapy. exclusion criteria: * any contraindication to initiation of either upadacitinib or adalimumab * unable to come to follow-up at 1, 3, and 6 months * current or planned (within 6 months) pregnancy or breastfeeding * inability to give informed consent * inability to communicate verbal or written responses to pain questionnaires * intraarticular steroid injections if done within 30 days of first visit * initiation of study intervention prior to baseline assessment * previous use of either study drug
treatment of abdominal distension by biofeedback - a randomized controlled trial

Conditions: Irritable Bowel Syndrome; Dyspepsia

Summary: background: abdominal bloating is a frequent and bothersome complaint in patients with functional gut disorders without satisfactory treatment to date. recent data from our laboratory indicate that abdominal distention in these patients is produced by abdomino-phrenic dyssynergia: diaphragmatic contraction associated with abdominal wall relaxation (particularly the internal oblique). in analogy to other clinical situations (e.g. functional outlet obstruction, rumination or aerophagia) behavioral treatment by means of biofeedback might be equally effective in these patients. the investigators hypothesized that abdomino-phrenic coordination and abdominal distention can be controlled by biofeedback techniques. aim: to prove the efficacy of behavioural treatment using biofeedback techniques for abdominal distension. randomization: patients will be randomized into biofeedback and placebo groups. intervention. biofeedback: patients will be taught to control abdominothoracic muscular activity by bio-feedback using online electromyography information. placebo: patients will be given a pill containing placebo medication. interventions will be delivered in 3 sessions (20 min each) over 10-day period . measurements: sensation of abdominal distension will be assessed by means of graphic rating scales graded from 0 (no perception) to 6 (very intense sensation). the activity of the abdomino-thoracic muscles will be recorded. abdominal distension will be measured by a metric tape fixed to a non-stretch belt placed over the umbilicus. outcomes: primary outcome: change in sensation of abdominal sensation. secondary outcomes: a) changes in thoraco-abdominal activity of the muscular walls; activity of thoraco-abdominal muscles (intercostals, diaphragm, external oblique, internal oblique, upper rectus, lower rectus) will be measured by electromyography; b) changes in girth; abdominal girth will be measured using a nonstretch belt (48mm wide) that is placed over the umbilicus. the overlapping ends of the belt will be adjusted carefully with two elastic bands to adapt constantly to the abdominal wall.


Eligibility criteria:
inclusion criteria: episodes of visible abdominal distension triggered by meal ingestion exclusion criteria: organic cause detected by clinical work-up

Keywords: gastrointestinal diseases irritable bowel syndrome behavioral research biofeedback
tissue-of-origin directing therapy in patients with cancer of unknown primary

Conditions: Cancer of Unknown Primary Site

Summary: this study is designed to evaluate the value of tissue-of-origin (origin-panca○r) profiling in predicting primary site and directing therapy in patients with cancer of unknown primary.


Eligibility criteria:
inclusion criteria: * had a diagnosis of cancer of unknown primary (cup) after a standard evaluation (medical history, physical examination, blood counts, chemistry profile, chest/abdomen computed tomography scans, positron emission tomography scan, and directed evaluation of all symptomatic areas). patients were required to have one of the following histologies: adenocarcinoma, poorly differentiated neoplasms, poorly differentiated carcinoma, squamous carcinoma. sufficient archived biopsy tissue from a surgical or core needle biopsy was required to perform the molecular profiling assay. eastern cooperative oncology group performance status of 0 to 2; no previous systemic therapy; measurable or evaluable disease (recist); and adequate organ function. exclusion criteria: * carcinoma limited to single site which can be potentially cured by surgery of radiotherapy.patients with symptomatic brain metastases, active clinical severe infection
evaluation of green tea as antioxidant agent in management of oral lichen planus

Conditions: Oral Lichen Planus

Summary: the study included forty individuals divided into 3 groups. 10 control subjects, 15 oral lichen planus (olp) patients who were treated with topical corticosteroids and 15 oral lichen planus (olp) patients who were treated with topical corticosteroids and green tea tablets.

this study included forty individuals divided into 3 groups. group a; 10 systemically healthy control subjects not receiving medication. group b; 15 patients who were previously diagnosed with olp presented in acute exacerbation were treated with topical corticosteroids; triamcinolone acetonide (kenalog in orabase: bristol-myers, squibb, spain) applied topically 4 times a day i.e. following each meal and at bed time for one month. group c; 15 patients who were previously diagnosed with olp presented in acute exacerbation were treated with both topical corticosteroids; triamcinolone acetonide (kenalog in orabase: bristol-myers, squibb, spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (green tea extract 5:1, el obour for modern pharmaceutical industries) as one tablet a day also for one month.

Eligibility criteria:
inclusion criteria: * patients presented with painful oral lichen planus lesions * free of any visible oral lesions other than oral lichen planus * free of any systemic diseases exclusion criteria: * topical treatment or systemic therapy of olp for one month before starting the study * pregnant or breast feeding women * smokers * use of corticosteroids or other immunosuppressive drugs
a phase 2 study of qlm3003 ointment in participants with mild or moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to assess efficacy, safety, and pharmacokinetics (pk) of qlm3003 ointment in participants with mild or moderate atopic dermatitis.

this study is a phase 2, randomized, double-blind,placebo controlled, parallel group study to assess efficacy, safety, and pharmacokinetics (pk) of qlm3003 ointment in participants with mild or moderate atopic dermatitis.

Eligibility criteria:
inclusion criteria: * the subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form. * ages at ≥18 and ≤ 65 years. * the diagnosis of atopic dermatitis will be confirmed according to the criteria of hanifin and rajka at the screening visit and have a clinical diagnosis of atopic dermatitis for at least 6 months. * have an investigator's global assessment (iga) score of 2, or3 at screening and at baseline. * have atopic dermatitis on the head (excluding hair-bearing scalp), neck, trunk, or limbs, covering at least 2% of total bsa and up to and including 20% of total bsa at screening and at baseline. exclusion criteria: * subjects with other dermatologic disease besides ad whose presence or treatments could interfere the assessment of disease (eg, psoriasis). * in the opinion of the investigator, have any clinically significant laboratory abnormality that would affect the participant's participation in the study. * use of topical treatments for ad within 2 weeks of baseline. * vaccinated or exposed to a live or attenuated vaccine within the 12 weeks of baseline, or is expected to be vaccinated these vaccines during treatment. * a history of alcohol or substance abuse within 12 months prior to screening that in the opinion of the investigator will preclude participation in the study.
preventing negative reactions in first time blood donors to encourage subsequent blood donations

Conditions: Syncope, Vasovagal

Summary: many individuals experience negative reactions when donating blood, including dizziness, lightheadedness, or fainting. such reactions may discourage them from donating again. this study will evaluate the effectiveness of pre-donation water consumption and a muscle tensing exercise during donation to reduce negative reactions among new blood donors. this study will also evaluate whether reducing negative reactions increases the likelihood of donors returning to give blood in the future.

severe and potentially dangerous shortages in the blood supply are increasingly common in the united states. as the population ages and as more stringent donor eligibility restrictions are enforced, blood shortages are expected to worsen. one way to meet the increasing demand for blood is to recruit new blood donors. ideally, these individuals would become lifelong donors, and contribute up to six times per year and up to hundreds of units of blood within a lifetime. unfortunately, less than half of all new donors provide a second donation. many individuals who donate blood experience dizziness, weakness, lightheadedness, or in severe cases, fainting. as a result of these negative reactions, many individuals never donate blood again. preventing these reactions may be an effective way to encourage subsequent blood donations. the purpose of this study is to evaluate the effectiveness of consuming water prior to donation and performing a muscle tensing exercise during donation as ways to reduce negative reactions in new blood donors. the study's long-term goal is to provide blood collection agencies with simple and inexpensive strategies to prevent negative reactions and enhance donor retention. this study will enroll american red cross blood donors who have donated blood no more than twice previously. participants will be randomly assigned to one of the following four groups: 1) pre-donation water consumption and muscle tensing exercise during donation; 2) pre-donation water consumption; 3) pre-donation muscle tensing exercise; or 4) no treatment. participant reactions will be assessed at the time of donation by self-report and phlebotomist ratings, as well as by self-report 24 hours following the donation. participants' subsequent donation history will be tracked for two years by reviewing the american red cross national donor database.

Eligibility criteria:
inclusion criteria: * must meet american red cross donor eligibility requirements exclusion criteria: * no more than two prior blood donations

Keywords: blood donation syncope vasovagal reactions
a new oral treatment for type ii diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for type ii diabetes mellitus.

a 12-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter, dose ranging study to evaluate the efficacy, safety and tolerability of gw823093, administered orally, once daily, as monotherapy in subjects with type 2 diabetes mellitus followed by a 12-week active treatment extension

Eligibility criteria:
inclusion criteria: * women must not be pregnant and must not be breastfeeding. * have type ii diabetes. * not taking any medicine for diabetes, or taking one oral medicine for their diabetes. exclusion criteria: * have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.

Keywords: niddm
efficacy and safety of a pentavalent rotavirus vaccine (brv-pv) against severe rotavirus gastroenteritis in niger

Conditions: Severe Rotavirus Gastroenteritis

Summary: the study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of brv-pv. three doses of brv-pv containing ≥ log10 5.6 ffu/dose of each serotype g1, g2, g3, g4 and g9 will be administered at 4 week intervals between doses. the first administration will occur at 6-8 weeks of age. we hypothesize a difference in vaccine efficacy of three doses of brv-pv vaccine vs. placebo against severe rotavirus gastroenteritis in healthy infants in niger. active surveillance for gastroenteritis episodes will be conducted throughout the trial. surveillance for adverse events will be carried out among all children from the time of first vaccination and 28 days post-dose 3. surveillance for all serious adverse events, including intussusception and death, will be conducted on all participants until they each reach two years of age. to assess the effect of prenatal nutrition supplementation on infant immune response to the brv-pv vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1 ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a lipid-based nutrition supplement. infants of participating women, if eligible at 6-8 weeks of age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter the main trial as part of the immunogenicity sub-cohort.


Eligibility criteria:
inclusion criteria: 1. aged 6-8 weeks at the time of inclusion 2. able to swallow and no history of vomiting within 24 hours 3. resident in madarounfa health district and within the catchment area of the central health facility 4. intending to remain in the study area for 2 years 5. parent/guardian providing written informed consent exclusion criteria: any of the following will exclude an infant from randomization in the study: 1. known history of congenital abdominal disorders, intussusception, or abdominal surgery 2. receipt of intramuscular, oral, or intravenous corticosteroid treatment within 2 wks 3. receipt or planned administration of a blood transfusion or blood products, including immunoglobulins 4. any known immunodeficiency condition 5. any serious medical condition 6. any other condition in which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or the parent/guardian's ability to give informed consent

Keywords: rotavirus gastroenteritis diarrhea vaccine niger